Director, Nonclinical Development and Pharmacokinetics

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

This role involves leading a dedicated team within the Development Sciences organization, collaborating with Discovery Sciences, Translational Medicine, and Regulatory teams, and providing scientific and strategic input to advance promising drug candidates to clinical trials. The ideal candidate will possess a strong background in pharmacokinetics, drug disposition, biodistribution, and translational pharmacology, with a proven track record in advancing molecules through CTA/IND milestones to first-in-human clinical trials.

Key Accountabilities/Core Job Responsibilities:

• Deliver on key Project Team objectives and advance portfolio of blood-brain-barrier penetrant TV biotherapeutics by providing scientific contributions in areas of pharmacokinetics, drug disposition and biodistribution, and translational pharmacology/pharmacodynamics

• Lead and manage a group within the Development Sciences organization, providing strategic project-focused vision and oversight to advance drug candidates from Discovery through CTA/IND-enabling studies into Early Clinical Development.

• Participate on Project Teams as a subject matter expert contributing to the optimization and selection of lead clinical candidates, and support Group members serving in this role

• Design nonclinical PK/PD studies to answer translational questions in support of project deliverables and first-in-human dose predictions; oversee TK analysis for non-GLP and GLP toxicology studies.

• Lead Project Teams or Pharmacology Technical Teams in the CTA/IND-enabling stage.

• Serve on the Development Sciences Leadership Team; set Function and Organizational goals.

• Establish and maintain productive relationships with key partners within the organization, including Discovery Sciences, Bioanalytical Sciences, Safety Assessment, Clinical Pharmacology, Translational Medicine, and Regulatory to advance projects to key decisions and achieve development milestones.

• Analyze, interpret, summarize and communicate data to internal project teams, senior management, global health authorities, and strategic partners.

• Author and review nonclinical and clinical sections of regulatory filings.

• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Qualifications/Skills:

• A highly motivated individual with a PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology/Toxicology, Engineering, or related field and 10 years of relevant work experience to include any postdoctoral work; must also have demonstrated experience as a people manager / mentor / coach

• Established expertise in biotherapeutic drug disposition and pharmacokinetics, with experience identifying clinical candidates and successfully advancing molecules through CTA/IND milestones to FIH clinical trials.

• Proven track record evaluating drug properties that may impact PK, investigating PK/PD relationships, and identifying relevant bioanalytical methods (ligand binding assays, mass spectrometry, or other methodologies) to assess biotherapeutic drug disposition.

• Well developed leadership skills in managing groups and developing scientific talent.

• Experience serving and/or leading cross-functional Project Teams, with success contributing to data driven decision-making, outlining strategies to enable drug development, and working collaboratively.

• Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results.

• Excellent oral and written communication and presentation skills.

Salary Range: $213,000.00 to $255,667.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.